Dolquine 300 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dolquine 300 mg film-coated tablets

hydroxychloroquine, sulfate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet:

1. What Dolquine is and what it is used for
2. What you need to know before taking Dolquine
3. How to take Dolquine
4. Possible side effects
5. Storage of Dolquine
6. Contents of the pack and other information

1. What Dolquine is and what it is used for

This medicine belongs to a group of medicines called antimalarials. It is used for:

Adults

• Treatment of acute or chronic rheumatoid arthritis.
• Treatment of systemic and chronic discoid lupus erythematosus.

Adolescents with body weight above 46 kg

• Prevention and treatment of uncomplicated malaria caused by plasmodium species sensitive to the drug (parasites that cause malaria), when first-line treatments are not suitable or not available.

2. What you need to know before starting Dolquine

Do not take Dolquine

• if you are allergic to hydroxychloroquine or to any of the other components of this medicine (listed in section 6).
• if you have any retinal disorders.
• for long-term treatments in children.
• if the malaria is caused by a chloroquine-resistant parasite, Dolquine cannot be used for prevention or treatment.
• if you are taking any of the following medicines:
  • Artemether/lumefantrine and mefloquine (used to treat malaria).
  • Natalizumab (used to treat multiple sclerosis).
  • Live attenuated viral vaccines.
  • Pimecrolimus and Tacrolimus (used to treat skin inflammation (eczema)).
  • Moxifloxacin (an antibiotic).
  • Agalsidase alfa and beta (used to treat a hereditary disorder called Fabry disease).

If you are unsure, speak with your doctor or pharmacist before taking this medicine.

Some people treated with this medicine may experience mental health problems such as irrational thoughts, anxiety, hallucinations, confusion, or depression, including thoughts of self-harm or suicide, even in individuals who have never had such problems before. If you or people around you notice any of these adverse effects (see section 4), consult a doctor immediately.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dolquine

• if you have:

• skin disorders such as psoriasis,

• severe kidney disease,

• deficiency of an enzyme called glucose-6-phosphate dehydrogenase (hemolytic anemia),

• any liver disease,

• myasthenia gravis (an autoimmune disease characterized by muscle weakness and fatigue),

• alcoholism.

• if the malaria-causing parasites are Plasmodium vivax and Plasmodium ovale, primaquine must also be administered to prevent relapses,

• if you are being treated with this medicine and have porphyria (a hereditary metabolic disorder), your condition may worsen,

• if you have neurological disorders (epilepsy),

• if you are an elderly patient, you should take special care to distinguish visual disturbances due to the disease or aging from those caused by the medicine,

• if you have visual disturbances. Before starting prolonged treatment with this medicine, your doctor will perform an eye examination and will then carry out periodic examinations. Consult your doctor as soon as you notice any visual changes.

• if you have an inactive chronic infection with hepatitis B virus.

Avoid exposure to sunlight (even when cloudy) and to ultraviolet (UVA) lamps while taking this medicine.

If you take this medicine for a long period, your doctor will likely perform periodic check-ups. You must report any new or unusual symptoms or circumstances during each visit to your doctor.

Hydroxychloroquine may cause a decrease in blood glucose levels. Please consult your doctor regarding the signs and symptoms of low blood glucose. It may be necessary to monitor your blood glucose levels.

Severe skin rashes have been reported with the use of hydroxychloroquine (see section 4, Possible side effects). These rashes often include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, inflamed eyes). Severe skin rashes are often preceded by flu-like symptoms such as fever, headache, and body aches. The skin rash may progress to widespread blisters and skin peeling. If you experience these skin symptoms, stop taking hydroxychloroquine immediately and contact your doctor without delay.

Other medicines and Dolquine

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Please note that these instructions may also apply to medicines taken before or that may be taken later.

Dolquine may affect the action of certain medicines, and some medicines may affect Dolquine.

Tell your doctor or pharmacist if you are taking any of the following medicines, as it may be necessary to adjust the dose of one or more of them:

• Kaolin and antacids.
• Medicines for diabetes such as insulin.
• Anthelmintics (used to eliminate intestinal worms).
• Antipsychotics: phenothiazines (used to treat mental disorders).
• Medicines used for heart conditions (digoxin and certain beta-blockers).

Some medicines may increase the number of side effects caused by Dolquine or reduce its effectiveness. These include:

• Dapsone (used to treat leprosy and certain skin diseases).
• Inactivated vaccines.
• Echinacea (a traditional herbal medicine used as supportive treatment for the common cold).
• Trastuzumab (used to treat certain types of cancer).

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Aminoglycoside antibiotics.
• Cimetidine (reduces acid production in the stomach).
• Neostigmine and pyridostigmine (for severe muscle weakness).
• Tacrolimus (used in organ transplantation).
• Phenylbutazone (a non-steroidal anti-inflammatory drug).
• Hepatotoxic drugs.
• Medicines that may cause skin irritation or damage to the liver or eyes.
• Bupropion (used to treat depression).
• Leflunomide (a disease-modifying antirheumatic drug).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

This medicine may be associated with a small increased risk of major congenital malformations and should not be used during pregnancy unless your doctor considers that the benefits outweigh the risks.

Breastfeeding

This medicine passes into breast milk. This medicine should not be used during breastfeeding unless your doctor considers that the benefits outweigh the risks.

Consult your doctor or pharmacist before taking any medicine if you are pregnant or breastfeeding. Your doctor will advise you whether this medicine is suitable for you.

Driving and operating machinery

Do not drive or operate tools or machinery until you know how this medication affects you. Adverse effects such as dizziness and visual disturbances may occur.

3. How to take Dolquine

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

• The tablets are taken orally.
• Swallow the tablets whole during meals or with a glass of milk.
• The score line is intended solely for splitting the tablet if you find it difficult to swallow it whole.

This medicine may not provide the exact dose you need throughout your treatment. Consult your doctor about using other presentations of Dolquine appropriate for each stage of treatment.

Recommended doses are:

Adults

• Treatment of rheumatoid arthritis
  • Initial dose: 400 to 600 mg daily according to the patient's response to the medication. If adverse effects occur, the initial dose should be reduced and then gradually increased after 5–10 days.
  • Maintenance dose: once an adequate response has been achieved (usually within 4–12 weeks), the maintenance dose is 200–400 mg daily.

The maximum daily dose for long-term treatment is 6.5 mg/kg of ideal body weight.

• Treatment of lupus erythematosus
  • Initial dose: 400 mg daily or 200 mg every 12 hours, depending on the patient's response.
  • Maintenance dose: 200 to 400 mg daily.

The maximum daily dose for long-term treatment is 6.5 mg/kg of ideal body weight.

Adolescents with body weight above 46 kg

• Prevention and treatment of uncomplicated malaria

Expert advice should be obtained. Before starting treatment, reliable tests must have identified the Plasmodium species and its sensitivity.

• Prevention of uncomplicated malaria: 6.5 mg/kg of ideal body weight once weekly, not exceeding 400 mg once weekly.

Prophylaxis should begin two weeks before exposure and continue for four weeks after leaving the endemic area. If prophylaxis was not started before exposure, a double initial dose may be administered in two separate doses 6 hours apart, followed by the standard regimen, continuing for up to 8 weeks after leaving the endemic area.

• Treatment of acute uncomplicated malaria attack:

First dose: 13 mg/kg, not exceeding 800 mg.

Second dose: 6.5 mg/kg, not exceeding 400 mg, 6 hours after the first dose.

Third dose: 6.5 mg/kg, not exceeding 400 mg, 24 hours after the first dose.

Fourth dose: 6.5 mg/kg, not exceeding 400 mg, 48 hours after the first dose.

The total maximum dose for the complete treatment course must not exceed 30 mg/kg of ideal body weight, without exceeding the recommended adult dose.

Use in patients with liver or kidney problems:

Your doctor will decide whether a dose adjustment is necessary if you have liver or kidney problems.

If you take more Dolquine than you should

If you take more medicine than you should, you may experience headache, drowsiness, visual disturbances, circulatory collapse, seizures, and cardiorespiratory arrest.

In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dolquine

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

Do not take a double dose to make up for missed doses.

If treatment with Dolquine is interrupted

Consult your doctor before stopping the treatment.

If you have forgotten to take several doses, consult your doctor for instructions on the dosing regimen to follow until you reach your maintenance dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking Dolquine and contact a doctor immediately if you notice any of the following serious adverse effects; you may need urgent medical treatment:

• Liver problems. Symptoms may include a general feeling of being unwell, with or without jaundice (yellowing of the skin and eyes), dark urine, nausea, vomiting and/or abdominal pain. Rare cases of liver failure (including fatal cases) have been observed.

• Serious skin reactions (see section 2, Warnings and precautions) such as:

  • rash with fever and flu-like symptoms and swollen lymph nodes. This could be a condition called drug reaction with eosinophilia and systemic symptoms (DRESS).
  • blisters, widespread scaly skin, pus-filled spots along with fever. This could be a condition called acute generalized exanthematous pustulosis (AGEP).
  • blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be a condition called Stevens-Johnson syndrome (SJS).
  • multiple skin lesions, itchy skin, joint pain, fever and general malaise. This could be a condition called toxic epidermal necrolysis (TEN).
  • skin reaction, including painful, raised plum-colored lesions, especially on the arms, hands, fingers, face and neck, which may also be accompanied by fever. This could be a condition called Sweet's syndrome.

Adverse effects may occur at certain frequencies, defined as follows:

Frequent (may affect up to 1 in 10 people)

• Headache.
• Problems in the cornea (a part of the eye) that may cause blurred vision, seeing halos, light sensitivity, and loss of visual acuity.
• Nausea, diarrhea, abdominal pain, loss of appetite and vomiting.
• Weight loss.

Uncommon (may affect up to 1 in 100 people)

• Emotional changes, feeling nervous, seeing, feeling, or hearing things that are not real—symptoms of psychosis.
• Seizures, uncontrolled eye movements.
• Deafness, ringing in the ears (tinnitus), and sensation of spinning (vertigo).
• Skin rashes of various types.
• Changes in the color of the skin and mucous membranes.
• Itching.
• Hair color changes (premature greying).
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Muscle disease.

Rare (may affect up to 1 in 1,000 people)

• Bone marrow failure (tissue inside the bone that produces blood cells).
• Retinal disorders (a part of the eye) that may lead to vision loss.
• Heart muscle disease.
• Muscle weakness.

Very rare (may affect up to 1 in 10,000 people)

• Abnormal liver function and liver failure.
• Psoriasis (a skin disease).

Frequency not known (frequency cannot be estimated from available data)

• Decreased number of blood cells (anemia, leucopenia, thrombocytopenia), breakdown of red blood cells (in individuals with Glucose-6-phosphate dehydrogenase deficiency), and agranulocytosis (lack of white blood cells).
• Nightmares.
• Inability to coordinate movements.
• Paralysis of the extraocular muscle.
• Sudden sensation of difficult breathing (bronchospasm) and respiratory failure.
• Urticaria (hives).
• Worsening or triggering of porphyria (a hereditary metabolic disorder).
• Irritability and fatigue.
• Loss of foveal reflex (retinal impairment (a part of the eye)).
• Decreased blood glucose levels.
• Depression or thoughts of self-harm or suicide.
• Hallucinations.
• Nervousness or anxiety.
• Confusion.
• Agitation.
• Difficulty sleeping.
• Euphoria or overexcitement.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of Adverse Reactions

If you experience any type of adverse reaction, consult your doctor, even if they are possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Dolquine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or in household waste. Unused medicines and their containers should be handed over to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dolquine

• The active substance is hydroxychloroquine sulfate. Each coated tablet contains 300 mg of hydroxychloroquine sulfate (equivalent to 232 mg of hydroxychloroquine base).

• The other components are:

  • Core: microcrystalline cellulose (E 460i), calcium hydrogen phosphate dihydrate, crospovidone,
    magnesium stearate (E 470b).

• Coating: Opadry Y-1-7000 White, the components of which are: hypromellose (E 464), macrogol, and titanium dioxide (E 171).

Appearance of Dolquiney, contents of the package

Oblong, white, film-coated tablets, scored on both sides.

Supplied in packs of 30 tablets.

Marketing Authorization Holder

PRODUCTS AND TECHNOLOGY, S.L

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal

Barcelona - Spain

Manufacturer

LABORATORIOS RUBIÓ, S.A.

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal

Barcelona - Spain

Local representative

LABORATORIOS RUBIÓ, S.A.

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal

Barcelona - Spain

Date of the most recent revision of this leaflet: March 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://aemps.gob.es/